Reported Feb 21, 2024 · Terminated

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only,…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

  • HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Lot codes and dates
    • Lot #: T04680
    • Exp. Date 6/2024
Amount recalled
8,198 units

Where it was sold

  • Nationwide

Why it was recalled

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 22, 2025 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.